Closure for packages of biological products



J. U. GhoULD 3,013,687

CLOSURE FOR PACKAGES OF' BIOLOGICAL PRODUCTS Filed Feb. 9, 1959 Dec. 19,1961 2 Sheets-Shes?l l VENT JA /-GUD Dec. 19, 1961 J, u. GoULD 3,013,687

CLOSURE FOR PACKAGES OF BIOLOGICAL PRODUCTS Filed Feb. 9, 1959 2Sheets-Sheet 2 256 INVENTOR.

JHK/f M GOUD J t "gw Q Unite States Patent hice 3,013,687 Patented Dec.19, 1861 3,013,687 CLOSURE FOR PACKAGES F `BIOLOGICAL PRODUCTS Jack U.Gould, Brooklyn, N.Y., assignor to Ferdinand Gutmann & C0., acorporation of New York Filed Feb. 9, 1959, Ser. No. 792,074 4 Claims.(Cl. 21S-38) The present invention relates to bottle closures that havespecialized utility in assuring maintenance of sterility afterwithdrawal of successive doses from the bottle by means of a hypodermicsyringe.

The present invention is a continuation in part of my earlierapplication, Serial No. 520,227 filed July 6, 1955, which issued asPatent No. 2,891,689 on lune 23, 1959.

It is among the objects of the invention to attain the advantages setforth in the earlier application above identified, with the use of thespecial form of gasket which the present application has in common withsaid earlier application and, in addition, to protect the entire area ofthe gasket face from access of dust or contamination until the outer ortear cap has been removed and access is first to Ibe had to thelbiologic preparation, yet to assure secure and permanent retention ofthe gasket in place and in one embodiment to protect the entire area ofthe gasket face from access of dust or dirt thereto after the outer tearcap has been removed and the hypodermic syringe needle repeatedlyinserted and withdrawn for removing each of successive doses from thebottle.

In the accompanying drawings in which are shown one or more of variouspossible embodiments of the several features of the invention,

FIG. 1 is a transverse sectional view of one embodiment of the inventionshowing the closure installed on a bottle;

FIG. 2 is a dropped side elevation of the component elements of theclosure in their correlation to the bottle neck to which the same is tobe applied;

FIG. 3 is a perspective view of the outer or tear cap of the closure;

FIG. 4 is a View similar to FIG. 1 of another embodiment of theinvention;

FIG. 5 is a view 'similar to FIG. 2 of the embodiment of FIG. 4;

FIG. 6 is a view similar to FIG. 3 of the `embodiment shown in FIG. 4;

FIG. 7 is a view similar to FIG. 1 showing 'a modification of theembodiment of FIGS. l, 2 and 3; and

FIG. 8 is a view similar to FIG. 4 of a modification of the embodimentof FIGS. 4, 5 and 6.

Referring now to FIGS. 1 to 3 of the drawings, the closure cap embodiesa gasket 12, preferably of a suitable formulation of natural rubber,though suitable synthetic elastomer or blends thereof, including orexcluding natural rubber, may serve for some uses. All 'such materialsare embraced within the term elastomer as used in certain of the claims.The gasket has an outer rim or annular portion 13 of yrelatively smallthickness, which ordinarily may ybe in the order of .050. That thicknessis adequate for effecting a complete seal against the rim 14 of thebottle neck 14 when the flange or skirt of a sheet metal cap of aluminumor other suitable material is crimped in place as more fully to bedescribed below, under the bead 17 around the rim of the bottle 14.

The central portion of the gasket 12 is of much greater thickness, whichserves as a pilot- 15 for proper positioning of the gasket, said pilotportion-being preferably in the order of .130 in thickness, which isordinarily required to assure adequate automatic reseal of the puncturein the gasket made by the needle of a hypodermic syringe (not shown),inserted for effecting removal of a dose of the biologic material fromthe bottle.

In a preferred application, the thickened or pilot portion 1S of thegasket extends wholly lbelow or from the underface of the annular rimportion 13 which is to rest upon the bottle rim 14', to which theclosure is to be applied. Thus in a preferred embodiment the rim wouldbe of thickness of about .050", as above indicated, while the center orpilot portion 1S would be of thickness in the order of .080 protrudingfrom the underface of the rim thickness.

The thicker pilot portion 15 of the gasket is to be accommodatedconcentrically in the neck of the bottle and has a maximum diametersomewhat less than the bore diameter of the bottle neck 14, thereby toextend loosely into said neck.

The closure in this embodiment includes two metal cap members, viz, aninner cap member 16, the cap disc of which has a large central aperture18 of diameter substantially equal to that of the pilot 1S of the gasketand a skirt or flange 19 and an annular rim 20. The closure also hasanouter cap 21 which completely encompasses the inner cap and comprisesa flange or skirt 23 and a cap disc 22 that covers the aperture 18 ofsaid inner cap 16, as well asits annular portion 20 that is inengagement with the annular rim portion 13 of the gasket 12.

The skirts 19l and 23 respectively of the inner cap 16 and the outer cap21 are of widths such as to afford facilities for crimping the same at25a under the bead 17 near the rim of the bottle neck 14 and thereby toexert and maintain pressure of annular rim 20 against the annular rimportion 13 of the gasket 12.

The outer cap 21 is preferably provided with a pull tab 24 protrudingdownwardly from the lower rim of skirt 23. Extending from the sides ofsaid pull tab 24 is a tear line extending at 25 the height of the sidewall o-f the cap and radially inward therefrom at 26, these radiallyinward portions 26 being connected by a circular tear line 27 which maybe concentric with the cap disc 22.

Thus when access is to be had to withdraw `biologic substance from theIbottle as it .comes from the manufacturer, the physician will grasp thepull tab 24 and sever the tear area by a sharp pull thereon, whereuponthe mutilated outer cap 21 may readily be removed from the bottle. Thus,the central aperture 1S of the inner cap 16 exposes substantially theentire central area of the gasket 12. The physician may now pierce thegasket with the needle of a usual hypodermic syringe and afterwithdrawal of said syringe with its contained dose of biologic material,the gasket of elastomer will reseal to close the little aperture thathad been made by the needle. The inner cap 16 crimped on as at 25amaintains the gasket 12 securely pressed at its rim 13 against the rim14 of the bottle neck, so that the gasket may again be pierced asrequired until the contents have been spent, by the needle of thehypodermic syringe for withdrawing further doses, it being understoodthat the physician will swab the exposed face of the gasket with alcoholto sterilize it prior to introducing the needle each time.

In the embodiment of FIGS. 4, 5 and 6, there is utilized in addition tothe inner cap 16 and the outer cap 21 an intervening dust cap 30. Theinner cap in the embodiment of FIGS. 4, 5 and 6 is identical with theinner cap 16 in the embodiment of FIGS. 1, 2 and 3. rI'he outer cap 21may also be identical with the outer cap 21 of FIGS. 1, 2 and 3, exceptthat illustratively, the tear cap has its pull tab 31 severed at 31'concentrically with the cap disc 22 about almost its entire periphery.Pull tab 31 may be of diameter approximately that of the centralaperture 18 in the inner cap, leaving the annular rim 20 in the disc ofcap 16. Weakened lines 33 extend outwardly from the root 32 of the pulltab 31 to the rim of the cap and thence downwardly at 34 along theflange or skirt 23 of the same.

The dust cap 30 has an imperforate end wall 36 and a flange or skirt 37of length or height less than those of the inner cap 16 and the outercap 21. Thus, in the closure as assembled to the bottle, the lower rimof the dust cap 30 is located above the lower edge of the maximumdiameter portion of the bottle bead 17', while the skirt 23 of the outercap 21 is of length sucient to be crimped under the bottle neck,together with the edge of the inner cap 16 whose skirt is also ofsufficient length to permit such crimping as best shown at Z in FIG. 4.

To gain access to the biologic substance in the embodiment of FIGS. 4 to6, the physician will grasp the pull tab 31 and pull outward anddownward thereon to remove the same, since the cap will tear along thetear lines 33 and along the tear lines 34 on the flange or skirt 23.Thus the cap 23' becomes split and may then readily be removed from thebottle. The physician will then remove the dust cap 30 thereby exposingthe aperture 1S' of the inner cap 16'. After penetration of the gasketwith a hypodermic needle and withdrawing a dose of biologic substancetherewith, immediate resealing of the little aperture formed in thegasket 12' by the needle will occur by virtue of the inherent resiliencyof the gasket 12. The physician will then slip the dust cap 30 on, thusprotecting the otherwise exposed central area of the gasket 12 fromaccess of dust or dirt. Access may be had again and again to thecontents of the bottle to remove successive doses in the mannerpreviously set forth.

Referring now to the embodiment of FIG. 7, which is a variant of FIGS.l, 2 and 3, the gasket is there shown with a pilot portion a and acorresponding upwardly extending portion 40. In other words, the pilotmay be of about one-half the thickness of that shown in FIG. l, theother half of that thickness being taken up by the portion 40 extendingabove the rim portion 13a of the gasket 12, Thus, the rim portion of thegasket may be of thickness of .050H as in the embodiment of FIGS. 1 to3, the pilot 15a of thickness of about .040, and the upwardly extendingcentral thickened portion 4t) also of thickness of about .040".

In this embodiment the central aperture 18a in the inner cap 16a is ofsuch diameter that the rim 20a will encompass with little clearance theupwardly extending gasket portion 40. The outer cap 21a is preferablydished slightly as at 41 to accommodate the protruding central thickenedportion 40 of the gasket.

The embodiment of FIG. 8 shows a variant of that of FIGS. 4 to 6,utilizing the same symmetrical gasket construction shown in theembodiment of FIG. 7, parts corresponding to those of FIGS. 4, 5, 6 and7 being designated by the same reference numbers with exponent b.

The invention in all of the embodiments described has the advantage thatunlike the elastic plug commonly used in the prior art, the gasketpermits venting or escape of compressed air by reason of its loose titbetween the thicker pilot portion of the gasket and the bore of thebottle neck, which is not permitted by the conventional plug which amongother drawbacks will when forced to position trap and greatly compressthe air above the biologic product, so that there is a tendency for thestopper to be propelled partly out of the bottle in subsequent expansionof such compressed air.

By reason of the pilot on the gasket, that gasket when laid upon thebottle after it has been charged with biologic material, will not becomedisplaced or slid of the bottle in the subsequent handling prior tocapping, nor will the gasket become displaced in the capping operation.

While the embodiments of FIGS. l to 6 are ordinarily preferred, theembodiments of FIGS. 7 and 8 have the advantage that the symmetricalconstruction of gasket dispenses with the need for guarding againstmechanically laying the gasket upon the bottle neck in reverse position.

Thus, by the present invention, all of the advantages of the specializedgasket shown in the drawings are attained,

while assurance is had that the loose-fitting gasket is yet maintainedsecurely in place upon the bottle by a cap for the purpose, which capaffords free access to the gasket by the hypodermic syringe, and thisdespite the complete removal of the outer tear cap present on theunopened bottle.

In the embodiments of FIGS. 4, 5, 6 and 8, the use of the dust cap whichis removable and replaceable after the outer or tear cap has beendiscarded, serves to protect the gasket from access of dust or dirt bycovering the large central aperture 1S or 18b in the inner cap 16 or 16brespectively.

After removal of the outer cap, a relatively large central area ofgasket becomes exposed, that area being substantially equal to that ofthe bore area of the bottle neck. Thus, the physician can puncture thegasket with a hypodermic needle repeatedly for withdrawing successivedoses of biologic substance until the bottle is empty, and this withoutlikelihood of two or more needle pricks through the gasket coming soclose together as to coalesce. This is to be contrasted with thediiculty arising where the well known flanged rubber stopper is used forthe purpose, for here the shank of the stopper is too thick forconvenient piercing by the hypodermic needle, so that there is availablebut a small portion near the very center of the stopper through whichalone the needle can penetrate. Thus, the danger of ineffective sealingby the elasticity of the rubber closure due to the coalescence of two ormore neighboring needle pricks is avoided by the present invention.

As many changes could be made in the above construction, and manyapparently widely different embodiments of this invention could be madewithout departing from the scope of the claims, it is intended that allmatter contained in the above description or shown in the accompanyingdrawings shall be interpreted as illustrative and not in a limitingsense.

Having thus described my invention, what I claim as new and desire tosecure by Letters Patent of the United States is:

l. A bottle closure of the character described, comprising animperforate gasket of elastomer with a thinner annular rim area forengaging the rim of a bottle and a thicker pilot portion substantiallyconcentric with and protruding below the bottom face of said rim areaand into the neck of the bottle, the maximum diameter of said thickerportion of the gasket being less than the bore diameter of said bottleneck, thereby loosely extending into said neck, said closure comprisingan inner cap of sheet metal having a central aperture of approximatelythe diameter of said pilot portion of the gasket, and an outer cap ofsheet metal encompassing the inner cap, both the inner and the outer caphaving skirt portions adapted to be secured to the mouth of said bottle,the outer cap portion having tear areas to facilitate its removal foraccess to the bottle contents by the needle of a hypodermic syringe topenetrate the gasket.

2. A bottle closure of the character described. comprising animperforate gasket of elastomer with a thinner annular rim area forengaging the rim of a bottle and a thicker pilot portion substantiallyconcentric with and protruding below the bottom face of said rim areaand into the neck of the bottle, the maximum diameter of said thickerportion of the gasket being less than the bore diameter of said bottleneck, thereby loosely extending into said neck, said closure comprisingan inner cap of sheet metal having a central aperture of approximatelythe diameter of said pilot portion of the gasket, a dust cap resting ontop of the inner cap and encompassing a substantial portion of its sidewall, an outer cap encompassing said dust cap, said inner cap and saidouter cap both having skirt lengths adapted to be secured to the mouthof said bottle, the dust cap having a skirt of lesser length than theinner and the outer cap to extend no further when assembled on thebottle than the region of maximum diameter of the bottle bead, the outercap having a tab portion to facilitate its removal from the bottle sothat access may be had thereto by removal of the dust cap and replacingthe dust cap after withdrawal of a dose by the needle of a hypodermicsyringe passed through the gasket.

3. A bottle closure of the character described, comprising animperforate gasket of elastomer with a thinner annular rim area forengaging the rim of a bottle and a thicker pilot portion substantiallyconcentric with and protruding below the bottom face of said rim areaand into the neck of the bottle, the maximum diameter of said thickerportion of the gasket being less than the bore diameter of said bottleneck, thereby loosely extending into said neck, said gasket havinganother concentric portion similar to the pilot portion extendingoutwardly from the rim area thereof, an inner cap having an annularportion over the rim portion ofthe gasket, encompassing the outwardlyextending portion of the gasket and an outer cap encompassing the innercap, and having a central domed portion to afford clearance for theoutwardly extending portion of the gasket, said inner cap and said outercap both having bottle, said outer cap having a tear portion tofacilitate its v removal from the bottle, the inner cap in the absenceof said outer cap maintaining the gasket securely assembled to thebottle.

4. The combination recited in claim 3 in which a dust cap intervenesbetween the inner and the outer cap, said dust cap being bowed at itscentral portion to accommodate the outwardly extending portion of thegasket, said dust cap having a flange narrower than that of the othercaps to facilitate its removal from the bottle after tearing away anddiscarding the outer cap.

References Cited in the le of this patent UNITED STATES PATENTS HoggSept. 15, 1942

